510(k) · Cleared
ClearedBunkerhill MAC
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
BunkerHill Health · JAK System, X-Ray, Tomography, Computed
Cleared on Oct 3, 2025 as substantially equivalent to K243229 (BunkerHill Health, 2025) and 1 other predicate after a 212-day review. Its family tree reaches back 14 generations to 1996.
- Decided
- Oct 3, 2025
- Review
- 212 days
- Class
- Class II
- Product code
- JAK
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 14 generations to K954678 (1996). 105 ancestors in all, the oldest K837107 (1983). No later device cites it as a predicate yet.
- Root · 14 generations backK954678 Pro VisionAlgotec Systems, Ltd. · 1996
- 10 generations between
- 3 generations backK210085 HealthCCSngZebra Medical Vision, Ltd. · 2021
- 2 generations backK230223 iCAC DeviceBunkerhill, Inc. · 2023
- 1 generation backK243229 Bunkerhill AVCBunkerHill Health · 2025
- This deviceK250662 Bunkerhill MACBunkerHill Health · 2025
Show all 14 generations
- Root · 14 generations backK954678 Pro VisionAlgotec Systems, Ltd. · 1996
- 13 generations backK980648 Pro VisionAlgotec Systems, Ltd. · 1998
- 12 generations backK992654 Plug 'N View 3D, Version 1.0Voxar Limited · 1999
- 11 generations backK022692 Voxelplus PacsMevisys Co., Ltd. · 2002
- 10 generations backK051528 Mevis Liveranalyser/Liverviewer SoftwareMevis Technology GmbH & Co. KG · 2005
- 9 generations backK061696 Iqqa-Liver SoftwareEdda Technology, Inc. · 2006
- 8 generations backK071310 Syngo CT Oncology Software PackageSiemens AG · 2007
- 7 generations backK083524 Syngo Dual Energy with Extended FunationallySiemens Medical Solutions USA, Inc. · 2009
- 6 generations backK112020 Syngo.CT Vascular AnalysisSiemens Medi Cal Solutions, Inc. · 2011
- 5 generations backK123585 Syngo, CT Cardiac FunctionSiemens Medical Solutions USA, Inc. · 2012
- 4 generations backK183268 AI-Rad Companion (Cardiovascular)Siemens Medical Solutions USA, Inc. · 2019
- 3 generations backK210085 HealthCCSngZebra Medical Vision, Ltd. · 2021
- 2 generations backK230223 iCAC DeviceBunkerhill, Inc. · 2023
- 1 generation backK243229 Bunkerhill AVCBunkerHill Health · 2025
- This deviceK250662 Bunkerhill MACBunkerHill Health · 2025
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −14 | K954678 | Pro Vision | Algotec Systems, Ltd. | 1996 | — |
| −13 | K980648 | Pro Vision | Algotec Systems, Ltd. | 1998 | — |
| −12 | K992654 | Plug 'N View 3D, Version 1.0 | Voxar Limited | 1999 | — |
| −11 | K022692 | Voxelplus Pacs | Mevisys Co., Ltd. | 2002 | — |
| −10 | K051528 | Mevis Liveranalyser/Liverviewer Software | Mevis Technology GmbH & Co. KG | 2005 | — |
| −9 | K061696 | Iqqa-Liver Software | Edda Technology, Inc. | 2006 | — |
| −8 | K071310 | Syngo CT Oncology Software Package | Siemens AG | 2007 | — |
| −7 | K083524 | Syngo Dual Energy with Extended Funationally | Siemens Medical Solutions USA, Inc. | 2009 | — |
| −6 | K112020 | Syngo.CT Vascular Analysis | Siemens Medi Cal Solutions, Inc. | 2011 | — |
| −5 | K123585 | Syngo, CT Cardiac Function | Siemens Medical Solutions USA, Inc. | 2012 | — |
| −4 | K183268 | AI-Rad Companion (Cardiovascular) | Siemens Medical Solutions USA, Inc. | 2019 | — |
| −3 | K210085 | HealthCCSng | Zebra Medical Vision, Ltd. | 2021 | — |
| −2 | K230223 | iCAC Device | Bunkerhill, Inc. | 2023 | — |
| −1 | K243229 | Bunkerhill AVC | BunkerHill Health | 2025 | — |
| 0 (this device) | K250662 | Bunkerhill MAC | BunkerHill Health | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1983 | 1 | 0 |
| 1987 | 1 | 0 |
| 1988 | 2 | 0 |
| 1991 | 2 | 0 |
| 1993 | 1 | 0 |
| 1994 | 2 | 0 |
| 1995 | 4 | 0 |
| 1996 | 5 | 0 |
| 1997 | 7 | 0 |
| 1998 | 6 | 0 |
| 1999 | 3 | 0 |
| 2000 | 6 | 0 |
| 2001 | 10 | 0 |
| 2002 | 4 | 0 |
| 2003 | 6 | 0 |
| 2004 | 7 | 0 |
| 2005 | 6 | 0 |
| 2006 | 5 | 0 |
| 2007 | 4 | 0 |
| 2008 | 5 | 0 |
| 2009 | 1 | 0 |
| 2011 | 2 | 0 |
| 2018 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in JAK? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new JAK device
- #1 K230223 iCAC Devicescore 23.5 · 12 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (2)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K243229 | Bunkerhill AVCSummary page 5…JAK Regulatory Class II Primary Predicate Device Proprietary Name Bunkerhill AVC Premarket Notification K243229 Classification Name Computed tomography x-ray system Regulation Number 21 CFR 892.1750 Product Cod… | 2025 |
| * | K230223 | iCAC DeviceSummary page 5…JAK Regulatory Class II Secondary Predicate Device Proprietary Name iCAC Device Premarket Notification K230223 Classification Name Computed tomography x-ray system Regulation Number 21 CFR 892.1750 Product C… | 2023 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 29 years and passes through 11 companies; a new generation was cleared every 1.8 years on median.
- 20 of the 105 ancestors have a recall of any class.
- 2 other devices also cite its predicate K243229.
How does its category compare?
All JAK devicesJAK System, X-Ray, Tomography, Computed: FDA decisions, review times, recalls and adverse event reports over 20 years. 2025, this device’s year, is highlighted.
FDA decisions per year · JAK
27in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · JAK
141in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · JAK
17in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · JAK
219in 2025
MAUDE reports naming product code JAK, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 14 | 27 | 11 | 76 |
| 2008 | 26 | 42 | 16 | 120 |
| 2009 | 15 | 31 | 29 | 105 |
| 2010 | 7 | 92 | 51 | 119 |
| 2011 | 16 | 155 | 34 | 205 |
| 2012 | 28 | 121 | 23 | 192 |
| 2013 | 17 | 132 | 11 | 414 |
| 2014 | 30 | 200 | 10 | 308 |
| 2015 | 30 | 140 | 28 | 454 |
| 2016 | 25 | 129 | 44 | 365 |
| 2017 | 29 | 96 | 33 | 338 |
| 2018 | 24 | 114 | 10 | 543 |
| 2019 | 28 | 94 | 5 | 233 |
| 2020 | 30 | 112 | 8 | 177 |
| 2021 | 20 | 145 | 15 | 261 |
| 2022 | 30 | 131 | 9 | 199 |
| 2023 | 27 | 139 | 9 | 310 |
| 2024 | 26 | 141 | 20 | 212 |
| 2025 | 27 | 141 | 17 | 219 |
| 2026 | 21 | 167 | 23 | — |
What is it indicated for?
Bunkerhill MAC is a software device intended for use in detecting presence and estimating quantity of mitral annulus calcification for adult patients aged 40 years and above. The device automatically analyzes non-gated, non-contrast chest computed tomography (CT) images collected during clinical care and outputs the region of interest (intended for informational purposes only) and quantification of detected calcium. The device-generated quantification…
Read the full statement (198 words)
Bunkerhill MAC is a software device intended for use in detecting presence and estimating quantity of mitral annulus calcification for adult patients aged 40 years and above. The device automatically analyzes non-gated, non-contrast chest computed tomography (CT) images collected during clinical care and outputs the region of interest (intended for informational purposes only) and quantification of detected calcium.
The device-generated quantification can be viewed in the patient report at the discretion of the physician, and the physician also has the option of viewing the device-generated calcium region of interest in a diagnostic image viewer. The subject device output in no way replaces the original patient report or the original non-gated, non-contrast CT scan; both are still available to be viewed and used at the discretion of the physician.
The device is intended to provide information to the physician to provide assistance during review of the patient’s case. Results of the subject device are not intended to be used on a stand-alone basis and are solely intended to aid and provide information to the physician. In all cases, further action taken on a patient should only come at the recommendation of the physician after further reviewing the patient’s results.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K250662 · printed Nov 5, 2026
Cite this page
510(k) Report. “K250662: Bunkerhill MAC.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K250662
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026